Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001024932
Ethics application status
Approved
Date submitted
10/09/2020
Date registered
8/10/2020
Date last updated
14/07/2024
Date data sharing statement initially provided
8/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparative assessment of the absorption of a test formulation of 1 x 12 mg (2E,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohexen-1-yl)nona-2,4,6,8-tetraenoic acid capsule against the innovator 2x 10 mg (2E,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohexen-1-yl)nona-2,4,6,8-tetraenoic acid capsules conducted under fed conditions in healthy male volunteers.
Scientific title
A Randomised, Open-Label Study to compare the Bioavailability of 1 x 12mg (2E,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohexen-1-yl)nona-2,4,6,8-tetraenoic acid capsule (Test) versus 2 x 10mg (2E,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohexen-1-yl)nona-2,4,6,8-tetraenoic acid capsules (Reference) in Healthy Male Subjects under Fed Conditions.
Secondary ID [1] 302116 0
None
Universal Trial Number (UTN)
U1111-1257-4717
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
(2E,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohexen-1-yl)nona-2,4,6,8-tetraenoic acid capsules are indicated for the induction of remission in patients with acute promyelocytic leukemia (APL), French-American-British (FAB) classification M3 (including the M3 variant), characterized by the presence of the t(15;17) translocation and/or the presence of the PML/RARa gene who are refractory to, or who have relapsed from, anthracycline chemotherapy, or for whom anthracycline-based chemotherapy is contraindicated. (2E,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohexen-1-yl)nona-2,4,6,8-tetraenoic acid is for the induction of remission only. 318744 0
Condition category
Condition code
Skin 316761 316761 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single dose, crossover study design whereby each participant receives the test formulation of (2E,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohexen-1-yl)nona-2,4,6,8-tetraenoic acid, 1 x 12 mg capsule on one occasion and the innovator formulation of (2E,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohexen-1-yl)nona-2,4,6,8-tetraenoic acid, 2 x 10 mg capsules on one occasion with each dose separated by a two week washout period. The intervention for this trial is the test formulation of (2E,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohexen-1-yl)nona-2,4,6,8-tetraenoic acid.

No water is allowed for 1 hour prior to dosing until 1 hour after dosing (except for the water consumed with each dose).

Participants are required not to eat for 10 hours before receiving a standardised high fat content meal and to fast for approximately 4 hours after each dose. The high fat content meal will consist of 2 eggs fried in butter, 2 slices of white toast, 120g hash brown patties, 2 slices of bacon and 240mL of whole milk comprising of approximately 800 to 1000 calories (approximately 50% of total caloric content of the meal derived from fat). This test meal will derive approximately 150, 250, and 500 600 calories from protein, carbohydrate, and fat, respectively.

Bathroom visits will be supervised to ensure no unauthorized water or food intake and for personal safety.

Participants will be confined at the Clinical Site for 12 hours prior to dosing to ensure compliance and for 12 hours after dosing.

Participants will be monitored for adverse events throughout the study.

Standard meals will be consumed at the Clinical Site with no additional food intake allowed. Alcohol breath testing & urine drugs of abuse will be performed upon each participant reporting to the Clinical Site 12 hours prior to dosing.

Pre and post study laboratory tests will be completed to assess the health of the participants along with HIV, Hepatitis and drugs of abuse testing.

Each dose will be taken orally with 240 ml of water at ambient temperature. Medication must be swallowed whole and a mouth check will be conducted to ensure that the medication has been taken as directed.
Intervention code [1] 318415 0
Treatment: Drugs
Comparator / control treatment
Single dose, crossover study whereby each participant receives the test formulation 1 x 12 mg (2E,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohexen-1-yl)nona-2,4,6,8-tetraenoic acid capsule on one occasion and the innovator formulation of 2x 10 mg (2E,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohexen-1-yl)nona-2,4,6,8-tetraenoic acid capsules on one occasion with each dose separated by a two week washout period. The comparator/control for this trial is the innovator formulation.
Control group
Active

Outcomes
Primary outcome [1] 324882 0
To evaluate the pharmacokinetics (as summarised by Cmax and AUC) of the test formulation relative to that of the reference formulation. All plasma samples will be assayed for
(2E,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohexen-1-yl)nona-2,4,6,8-tetraenoic acid using one fully validated LC/MS/MS method. Validation will be conducted to comply with FDA guidelines.
Timepoint [1] 324882 0
The sampling intervals will be at -1, -0.5, 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 11 and 12 hours post dosing.
Secondary outcome [1] 386092 0
Time to maximum peak concentration (Tmax) will be determined by plasma sample analysis. Tmax will be the time where the maximum concentration occurred in the sample points.
Timepoint [1] 386092 0
The sampling intervals will be at -1, -0.5, 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 11 and 12 hours post dosing.

Eligibility
Key inclusion criteria
Healthy males
Aged between 18 and 55 years
Non-smoker
BMI greater than or equal to 18.5 and less than 29.9 inclusive
Normal, healthy individuals as determined by medical history, physical examination, ECG, blood pressure and laboratory tests
Drug free as determined by urine drug testing
Able to comply with the study restrictions
Able to provide written informed consent
Minimum age
18 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Clinically significant medical conditions
History of conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug
History of alcohol or drug abuse or dependency
Participation in a drug study within 60 days of the start of the study
Sensitivitie to the study drug or excipients
Individuals for whom the Clinical Investigator believes, for any reason, that participation would not be an acceptable risk

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All formulations will be labeled as Formulation A and B. The identification of each treatment will only be known to the Managing Director and Section Head - Trials and Regulatory Affairs or their delegate.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Each participant will be identified by a 3 digit screening number and a 2 digit subject number. The screening number will be issued once the participant has given written consent to participate in the study and the two digit study number (randomisation number) after acceptance into the study. Randomization will be performed using a randomisation table created by computer software (i.e. computerized sequence generation).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Bio-equivalence
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
17/10/2020
Date of last participant enrolment
Anticipated
Actual
17/10/2020
Date of last data collection
Anticipated
Actual
31/10/2020
Sample size
Target
18
Accrual to date
Final
18
Recruitment outside Australia
Country [1] 22876 0
New Zealand
State/province [1] 22876 0
Otago

Funding & Sponsors
Funding source category [1] 306538 0
Commercial sector/Industry
Name [1] 306538 0
Douglas Pharmaceuticals Ltd
Country [1] 306538 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Zenith Technology Corporation Limited
Address
156 Frederick Street
Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 307068 0
None
Name [1] 307068 0
Address [1] 307068 0
Country [1] 307068 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306734 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 306734 0
Ethics committee country [1] 306734 0
New Zealand
Date submitted for ethics approval [1] 306734 0
26/08/2019
Approval date [1] 306734 0
30/09/2020
Ethics approval number [1] 306734 0
20/NTA/139

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104838 0
Dr Noelyn Hung
Address 104838 0
Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
Country 104838 0
New Zealand
Phone 104838 0
+64 3 477 9669
Fax 104838 0
+64 3 477 9605
Email 104838 0
[email protected]
Contact person for public queries
Name 104839 0
Linda Folland
Address 104839 0
Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
Country 104839 0
New Zealand
Phone 104839 0
+64 3 477 9669
Fax 104839 0
+64 3 477 9605
Email 104839 0
[email protected]
Contact person for scientific queries
Name 104840 0
Tak Hung
Address 104840 0
Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
Country 104840 0
New Zealand
Phone 104840 0
+64 3 477 9669
Fax 104840 0
+64 3 477 9605
Email 104840 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
All data will be compiled into a final report that is the property of the sponsor company. All participant data will be provided in summary format and result of the study only will be reported


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.